Walking a Labyrinth
Edited by Eljalill Tauschinsky and Wolfgang Weiß
Chapter 5: Delegated and implementing acts in the regulation of pharmaceuticals – an analysis through the lens of subsidiarity
This chapter examines whether the subsidiarity principle influences the legislative choice between delegated and implementing acts, using the regulation of pharmaceuticals in the internal market as a case study. Whereas delegated acts have to be examined in the context of legislative subsidiarity due to their quasi-legislative nature, implementing acts affect the competences of the Member States to implement EU legislation under the principle of executive federalism. It is argued that as the constitutional differences of control for these types of acts have to a certain degree been blurred, subsidiarity seems to be less relevant in the choice between delegated and implementing acts, even in a regulatory area with complex competence divisions between the Union and the Member States.
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